NCT04936594

TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA)

Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Gopalkumar Rakesh · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The pilot study proposal aims to modulate craving and attentional bias towards smoking cues in 40 people living with HIV/AIDS (PLWHA) using transcranial magnetic stimulation (TMS), with functional MRI (fMRI) brain correlates. TMS is a form of noninvasive brain stimulation and modulates neural activity using tiny doses of focused electricity. For the study, participants would perform two cognitive tasks and neuroimaging before and after the TMS and investigators would compare changes in these paradigms with TMS. The investigators will also get a point of contact urine drug screen before study initiation. The investigators will aim to recruit 20 subjects in each arm of our trial (total of 40) from the BlueGrass HIV Clinic.

Detailed description

People living with HIV/AIDS (PLWHA) smoke at nearly three times the rate of the general population. These extraordinary smoking rates are associated with greater AIDS-related cancer, non-AIDS related morbidity including non-AIDS-defining cancer, cardiovascular disease, pulmonary disease, and mortality. Smoking significantly impacts the progression and outcome of HIV disease and has been identified as the leading contributor to premature mortality in PLWHA. Suboptimal results with current smoking cessation strategies makes identifying new adjunct strategies an area of need. The pilot study proposal aims to modulate craving and attentional bias towards smoking cues in people living with HIV/AIDS (PLWHA) using transcranial magnetic stimulation (TMS), with functional MRI (fMRI) brain correlates. TMS is a form of noninvasive brain stimulation and modulates neural activity using tiny doses of focused electricity. The TMS paradigm we would be performing is called theta burst stimulation (TBS), which is potent, short, and efficient. It has shown to cause neuroplasticity even with a single session and was approved by the FDA for treatment of major depressive disorder in 2019. Targeting the left dorsolateral prefrontal cortex (DLPFC) by using MNI coordinates (-44,40,29) via Brainsight Neuronavigation will modulate craving and attentional bias that is closely associated with craving. For this pilot study, 40 participants will perform the attentional bias task, craving scale and neuroimaging before and after the TBS/ sham TMS session, to compare changes in these paradigms between these interventions. Attentional bias would be measured with eye tracking, craving will be assessed with tobacco craving questionnaire (TCQ-SF). The investigators will aim to recruit 10 subjects from the BlueGrass HIV Clinic, who have an established pipeline for enrolling PLWHA patients in clinical trials. Although there is limited data on TMS in smoking, there have been no TMS studies done in PLWHA

Conditions

• Smoking Cessation
• HIV
• Craving

Interventions

Type	Name	Description
DEVICE	iTBS	1800 pulses of iTBS
DEVICE	TMS	MagVenture MagPro x100 device. This will be used as the comparator.

Timeline

• Start date: 2021-05-24
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2021-06-23
• Last updated: 2023-07-13
• Results posted: 2023-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study